Investigation of Anti-TNF-α (Infliximab) drug effectiveness in COVID-19 patients
Design
The study is a clinical trial, in parallel and double-blind, which will be performed on 40 people by block stratified randomization.
Settings and conduct
This is a double-blind study in which participants, health professionals, researchers, evaluators do not know whether the patient is receiving medication or a placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria include confirmation of the patient's test to Covid by RT-PCR or CT scan. Also, people who have oxygen levels below 88% and have high levels of inflammatory factors. Also excluded from the study were people with neurodegenerative diseases or conditions such as heart failure, high blood pressure, and active infections other than COVID 19.
Intervention groups
There are 2 intervention groups, including the group receiving the infliximab drug and the group receiving the placebo. Both groups of patients with Covid-19 have severe to critical clinical conditions
Main outcome variables
Changes in blood oxygen levels, ferritin, di-dimer, C-reactive protein as well as changes in white blood cell percentage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201229049873N1
Registration date:2021-05-23, 1400/03/02
Registration timing:retrospective
Last update:2021-05-23, 1400/03/02
Update count:0
Registration date
2021-05-23, 1400/03/02
Registrant information
Name
Jafar Majidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 0759
Email address
st-majidi.j@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-22, 1399/11/03
Expected recruitment end date
2021-03-13, 1399/12/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of Anti-TNF-α (Infliximab) drug effectiveness in COVID-19 patients
Public title
Infliximab effectiveness in COVID-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Covid-19 with acute respiratory symptoms between the ages of 18 and 60 who test positive for the SARS-CoV-19 virus by RT-PCR or by CT scan. Lung scan (subpleural lung involvement, bilateral circumference, and more than one area).
Saturated oxygen is below 88%
Respiratory rate more than 24 times per minute
high CRP and D-dimer level, also ferritin above 1000
Lymphopenia with a count of less than 1100
Exclusion criteria:
Patients who have a positive test for PPD, HCV, HBS
Patients Have a history of neurodegenerative diseases such as multiple sclerosis
Patients with heart failure, hypertension, and infections other than Covid 19 infection.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was performed by block stratified randomization method in which the class of material and block size of four people were considered. Male and female patients were divided into quadruple blocks, respectively. In each block, two patients were randomly assigned to the intervention group and two patients to the control group. Randomization was performed for men and women separately so those female patients and male patients were placed in blocks separately. The randomization list was extracted by the software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the drugs are coded A and B. None of the participants, health personnel, researchers, evaluators, and analysts know which drug code and which placebo code.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahre-Kord University of Medical Sciences
Street address
Kashani ave
City
Shahre-Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Approval date
2020-12-23, 1399/10/03
Ethics committee reference number
IR.SKUMS.REC.1399.227
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Changes in paraclinical outcomes
Timepoint
At the beginning of the study (before the intervention) and 7 and 14 days after the start of treatment
Method of measurement
Clinical and laboratory testing
2
Description
Blood oxygen levels
Timepoint
At the beginning of the study (before the intervention) and 7 and 14 days after the start of treatment
Method of measurement
Pulse oximeter
3
Description
Duration of hospitalization
Timepoint
From the beginning of the study.
Method of measurement
Clinical and vital signs
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group:" Patients with Covid 19 who, in addition to the usual treatment regimens, receive a single dose of infliximab (4 mgr/kg) for 2 hours by infusion. The patient will be evaluated for vital signs, oxygen levels, and laboratory parameters at baseline and on the seventh and fourteenth days..
Category
Treatment - Other
2
Description
"Control group: "Patients with Covid 19 receiving common treatment regimens also receive a placebo. The patient will be evaluated for vital signs, oxygen levels, and laboratory parameters at baseline and on the seventh and fourteenth days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar hospital
Full name of responsible person
Ahmad Raeisi
Street address
Hajar hospital,Parastar ave
City
Shahre-Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۷۵۴۶۳۳
Phone
+98 38 3222 1943
Email
Hajar-Hospital@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehreban Sadeghi
Street address
Kashani ave
City
Shahre-Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
sadeghi@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Akbar Soleymani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pulmonary Diseases
Street address
Kashani hospital,Parastar ave
City
Shahre-Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۷۵۸۹۱۵
Phone
+98 38 3226 4825
Email
dr.akbarsoleymani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mohammad Moosavi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
Hajar hospital,Parastar ave
City
Shahre-Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816854633
Phone
+98 38 3222 1943
Email
moosavi@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Jafar Majidi
Position
Student
Latest degree
Master
Other areas of specialty/work
Immunology
Street address
Department of immunology, School of Medicine, Shahre-Kord university of medical science, Rahmatiyeh
City
Shahre-Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3333 5653
Email
st-majidi.j@skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All potential data can be shared after blinding
When the data will become available and for how long
Six mounts after publishing
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For research purposes and meta-analysis studies
From where data/document is obtainable
Jafar Majidi, Department of immunology, School of Medicine, Shahre-Kord University of Medical Sciences, Rahmatieh
What processes are involved for a request to access data/document